Roche snags FDA nod for 'breakthrough' Rituxan successor

Just as biosimilar competition creeps up on blockbuster Rituxan, Roche ($RHHBY) and partner Biogen Idec ($BIIB) have won FDA approval for the cancer drug's heir, marking the first success story for the agency's breakthrough drug designation.

GA101, now dubbed Gazyva, is designed to treat chronic lymphocytic leukemia (CLL) by targeting cells with the cancer-tied CD20 marker, spurring the immune system to join in on the fight. In late-stage studies, the drug beat out its multi-billion-dollar forebear Rituxan when paired with chemotherapeutic chlorambucil, helping CLL patients live longer without their cancer worsening, and Gazyva more than doubled progression-free survival compared to chlorambucil alone.

The drug, discovered by Roche's Swiss R&D group, picked up the FDA's coveted breakthrough designation over the summer on the strength of some promising Phase III data. Gazyva's approval is the first under the new program, and Friday's FDA go-ahead comes a month and change earlier than the agency's stated Dec. 20 decision date.

Analysts peg Gazyva's peak sales at between $1.5 billion to $2.5 billion a year, far below Rituxan's $6 billion annual haul but still a welcome addition as biosimilars threaten to eat away at the blockbuster's sales. And, considering Roche's strong track record with drug launches and marketing, the partners have a chance to exceed expectations.

For Genentech, the Bay Area engine driving much of Roche's recent success, Gazyva makes for 5 FDA approvals in the past three years, and medical chief Hal Barron said he believes the latest compound has benefits beyond its indication.

"We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers," Barron said in a statement.

According to the National Cancer Institute, about 15,680 Americans will be diagnosed with CLL this year, and 4,580 will die from it.

- read Roche's statement
- check out the FDA release

Special Report: 10 top drugs in biopharma's late-stage pipeline - Obinutuzumab/GA101, Roche and Biogen Idec